Identity
- Trade Name
- Mack's FDA UDI
- Generic Name
- Earplugs, reusable FDA UDI
- Device Name
- Moldable Silicone Earplugs - 18 Pair Box FDA UDI
- Model / Reference
- Pillow Soft Silicone Putty Earplugs FDA UDI
- Description
- Moldable Silicone Earplugs - 18 Pair Box FDA UDI
Identifiers
- Catalog Number
- 718 FDA UDI
- Primary DI / UDI-DI
- 00033732007184 FDA UDI
- FDA Product Code
- EWD FDA UDI
- GMDN Term
- Earplugs, reusable FDA UDI
Classification
- Device Class
- U FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
Yes
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Earplugs, reusable
Mack's by Mckeon Products — Class U — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class U | Pending data |
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Manufacturer
- Manufacturer
- Mckeon Products
Sources (1)
- FDA UDI c15f89c8-aa81-47bb-8154-2c7840a98f36 34 fields · synced Jun 8, 2026